Personal Protective Equipment
Personel Protective Equipments are evaluated under 2016/425/EU Personel Protective Equipment Directive issued by the European Commission. The 2016/425 /EU Personal Protective Equipment Directive has determined three categories: category I, II and III. Products are evaluated and certified according to these categories for conformity. At the end of the successful certification process, the manufacturer has the right to affix CE labels to its products.
Protective Clothing Against Infective Agents
EN 14126 standard covers overalls that protect against infective agents and microorganisms. The standard has determined 6 different classes. Depending on how long it protects the person wearing the protective clothing against infective microorganisms, it has determined 6 different classes as follows.
Additional standards are required in the conformity assessment and certification processes for manufacturers that produce according to the EN 14126 standard and have to affix the CE label to their products. EN 14126 standard cannot be used alone. EN 13034 (Clothing That Protects Against Liquid Chemicals) and EN ISO 13982-1 (chemical protective clothing that protects the body against chemical particles emitted by air) are complementary standards of EN 14126 standard and protective clothing must meet the requirements of these standards in the certification process.
Protective clothing within the scope of EN 14126 standard is classified as Category III in the regulation. The certification process for the products in this category is as follows;
- Step :EC Type Examination Certification
Module B Certificate
For this, the manufacturer should create a technical file containing all the details of the products’ features. In addition, product samples must be tested in the accredited laboratory of the notified body. ‘EC Type Examination Certificate’ is published after the technical file is approved and the tests are completed successfully. The validity of the certificate is 5 years.
- Step : Module C2 or Module D Certificate
The EC Type Examination Certificate alone does not offer the right to affix CE labels to products. In addition to the Type Examination Certificate, manufacturers who want to attach a CE label to their products must have a certificate according to one of the following options. Manufacturers determine which complementary modules to implement.
- Option Module C2 Certificate (Conformity to based on internal control of production)
The Notified Body performs the production control stages carried out by the manufacturer regarding the mass production of the products and the inspection and tests carried out at the factory. In addition, in order to ensure the validity of the certificate, the notified body conducts audits at the production facility at least once a year at random intervals. The validity of the module C2 certificate continues depending on the realization of surveillance audits.
- Option Modul D Certificate (Conformity to based on the quality assurance of the production)
Manufacturers who prefer to receive certificates according to this module must operate a quality management system. The notified body carries out the inspection of the quality management system applied at the production facility and publishes the certificate after the positive inspection.
In summary, protective clothing manufacturers who want to affix CE labels to their products must have obtained Module B + Module C2 or Module B + Module D certificates. For more detailed information, you can review the regulation or contact Szutest Uygunluk Değerlendirme A.Ş. experts and get information.